oCare
- Primary DI
- 04719876230010
- Brand
- oCare
- Company
- TAIWAN BIOPHOTONIC CORPORATION
- Model
- Pro100
- Catalog number
- Pro100
- Device description
- The oCare Wrist Pulse Oximeter, Model Pro 100, is a wrist-worn device indicated for use in noninvasive measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The intended measuring site of this device is the wrist skin surface. It is intended for spot-checking or continuous monitoring of adult patients during no motion conditions, in hospitals, hospital-type facilities, and home environments.
- Published
- 2021-02-25
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DQA | Oximeter | Cardiovascular | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K183556 | 000 | oCare Wrist Pulse Oximeter | Taiwan Biophotonic Corporation | 2019-02-15 | DQA |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 04719876230010 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 04719876230010 | 04719876230010 | 4719876230010 |
GMDN Terms
| Term | Definition |
|---|
| Pulse oximeter, battery-powered | A portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home. |
Regulatory Flags
- DUNS number
- 658871879
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 04719876230027 | oCare | Pro100 | | 2021-04-12 |
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